Did you know this version of Internet Explorer is out of date?

To get the latest experience from our website, please upgrade your browser.

Have a drug or medical device concern?

call

Proton Pump Inhibitors

A A

Proton pump inhibitors are medications that reduce the production of stomach acid, which can cause conditions like acid reflux and heartburn. They are popular choices to help patients deal with symptoms, and Americans spend billions on them each year. However, studies link these seemingly harmless drugs to significant medical problems — from heart attacks to kidney disease — in users across the globe.

Proton pump inhibitors (PPIs) are powerful acid reduction drugs. They target gastric acid, which is generated by the stomach as a digestive agent. When a person’s body overproduces gastric acid or the acid migrates to places it should not be, such as the esophagus, the person experiences tremendous discomfort.

Gastric acid issues either cause or exacerbate a number of medical problems. Patients use PPIs to treat these illnesses, including:

  • Acid reflux
  • Heartburn
  • Peptic ulcers
  • Gastritis
  • Barrett’s esophagus
  • Allergic esophagitis
  • Gastrinomas or other stomach tumors
  • Zollinger-Ellison syndrome

These medications are among the most commonly used drugs in the world. Approximately 20 million people in the U.S. use PPIs, spending almost $14 billion on them each year. Some PPIs are available over the counter, while others are only available through a prescription.

Doctors prescribe these medications to people of all ages, though some populations must be more careful with these drugs than others. For example, users over 50 are more likely to experience certain side effects, such as fractures. Doctors may prescribe these drugs to infants who suffer from gastric acid-related illnesses but must closely supervise the dose.

Like most medications, all PPIs are accompanied by uncomfortable yet minor side effects, such as headaches and nausea. However, new research shows links between PPI usage and a variety of severe side effects, such as cardiovascular disease and bone fractures.

If you took Proton Pump Inhibitors and struggled with kidney problems, you may have legal options.

How Proton Pump Inhibitors Work

When PPIs enter the bloodstream, they signal acid-forming cells in the stomach lining to stop producing so much gastric acid. This often results in lessened discomfort for the PPI user.

Because PPIs lessen the amount of gastric acid present in the stomach, they are often prescribed to ulcer patients. Gastric acid is necessary for the formation of most ulcers, so if it is not present in great quantities, ulcers are able to heal.

Common PPI Medication Side Effects

Proton Pump Inhibitors can cause a number of uncomfortable side effects, including infection. Gastric acid is responsible for killing some harmful bacteria in the stomach. Thus, when gastric acid is reduced and unable to continue eliminating as much bacteria, PPI users become susceptible to a host of infections, such as C. difficile. Researchers recently released a study that suggests PPIs may have a link to damaged arteries. Increased risk of heart attack, kidney failure and dementia could follow, researchers said.

Some of the most frequently experienced PPI side effects are as follows:

  • Headaches
  • Joint pain
  • Rash or other skin issues
  • Anxiety
  • Dizziness
  • Constipation
  • Severe diarrhea
  • Malabsorption of nutrients

Due to the wide range of side effects that PPI users have reported, these drugs have been investigated by researchers. Evidence against the safety of PPIs is constantly emerging. More and more clinical studies are showing that life-changing side effects are less uncommon than previously thought.

Serious Medication Side Effects

Unfortunately, the PPI side effects do not end with relatively minor problems such as mild constipation and dizziness. The following serious side effects have been linked to PPI use:

Clinical Studies

Though PPIs offer value and relief to many people, they are not universally beneficial. In fact, a study by the San Francisco Department of Public Health estimated that only 30 to 40 percent of PPI users actually require the medications. The remaining 60 to 70 percent of patients should instead try lifestyle changes and antacids.

In addition, researchers have conducted a number of studies on the side effects and complications of PPI use, including kidney failure, heart attack, dementia and more.

There has been a grave association made between PPIs and cognitive decline. In 2011, a group of German physicians and researchers concluded a seven-year study involving 73,679 elderly persons, all of whom were free of dementia at the start of the study. Approximately 3,000 of the subjects were regular users of PPIs. The researchers found that the PPI users had a significantly increased risk of dementia.

Additionally, there is a link between PPIs and kidney disease and kidney injury. A group of Canadian researchers reviewed nine years of medical records of 290,592 people, and discovered that PPI users were more likely suffer from acute kidney injury than non-PPI users. Also, in 2016, the Journal of the American Medical Association released a report showing that PPI users were much more likely to experience chronic kidney failure.

The Stanford School of Medicine conducted a study involving the health records of 3 million Americans, a portion of which were PPI users. Researchers found that there is an association between usage of PPIs and heart attacks, and showed a 20 percent increase in risk of heart attack after using these medications.

Infection is more common in those who use PPIs. Researchers in Denmark found that PPI users were 50 percent more likely to acquire pneumonia while in a hospital.

The University of Maryland reported that certain PPIs (Prevacid, Nexium, and Prilosec and its generics) can increase the risk of bone breaks in people who use the medications for more than one year. Specifically, the bones that are prone to breaking due to PPI use are those within the wrists, hips, vertebrae and forearms.

FDA Warnings

Since 2010, the U.S. Food and Drug Administration (FDA) has released warnings that PPIs can contribute to the following conditions:

  • Diarrhea associated with C. difficile infection
  • Low magnesium levels
  • Risk of fractures of the hip, wrist and spine

The FDA stated on multiple occasions that longer durations of PPI usage increase the risk of these conditions. Thus, the FDA advises careful use of PPIs. The drugs should never be used for longer than 14 days, on three separate occasions within one year. The FDA recommends trying antacids before resorting to PPIs.

Proton Pump Inhibitor Medications

There are several PPI medications on the market, each with its own unique set of side effects. However, they have all been linked to some major side effects, such as heart attacks.

Omeprazole (Prilosec)

This medication is made by AstraZeneca. Prilosec is a once-daily pill that is intended to relieve heartburn symptoms for 24 hours. Patients are advised to limit their Prilosec usage to 14 days at a time, no more frequently than every four months. Prilosec side effects many users experience include headache and diarrhea.

Esomeprazole (Nexium)

This medication is manufactured by AstraZeneca. As one of the top-selling prescription medications in the U.S, this PPI alone pulls in billions of dollars in annual sales. Doctors prescribe Nexium in dosages for no longer that eight weeks for acid reflux issues, and six months for ulcer healing purposes. The most common Nexium side effects include are headache, nausea, stomach pain, dry mouth, diarrhea, gas, constipation and drowsiness.

Lansoprazole (Prevacid)

Prevacid is manufactured by Takeda Pharmaceuticals. This medication is intended for short-term treatment of acid-related medical issues and healing of stomach ulcers.

There are several subgroups of Prevacid, some of which are advised for once-daily dosing, others for twice-daily dosing, and still others for thrice-daily dosing, sometimes for up to 12 weeks. Some lansoprazole medicines are available over-the-counter and others are by prescription only. Most prescription forms of lansoprazole are intended for once-daily dosing.

Prevacid is a delayed-release medication, which means that it is broken down in the intestine rather than the stomach. It can take several days for users to experience relief, so this medication is not an immediate fix for heartburn.

The most common Prevacid side effects include diarrhea, stomach pain, nausea, constipation and headache. Users over age 50 should check with their doctor before taking this medication. Being over 50 is a risk factor for an infection that causes severe diarrhea, and also bone fractures.

Dexlansoprazole (Dexilant and Kapidex)

Delixant is manufactured by Takeda Pharmaceuticals. Doctors prescribe Delixant (formerly called Kapidex) to relieve symptoms of GERD.

The drug can be taken for up to six months. This medication comes in once- and twice-daily doses. It is a delayed-release medication, so it begins working one hour after the medication is taken, and then another medicine release occurs four hours after it is taken. Dexlansoprazole must be taken at the same time each day.

Users should avoid alcohol, and expect common Dexilant side effects such as diarrhea, stomach pain, nausea, common cold, vomiting and gas. People over age 50 are advised to check with their doctor before using this medication, as that population is more prone to some of its side effects, including severe diarrhea and hip, wrist and spine fractures.

Pantoprazole (Protonix)

Protonix is manufactured by Wyeth Pharmaceuticals. Doctors prescribe Pantoprazole to relieve symptoms of GERD and EE. It helps to heal the esophagus from gastric acid-related damage, and prevent further damage.

Doctors prescribe this medication for up to eight weeks, taken either once or twice per day. It is available in pill form, and also in granule form, which can be mixed into apple juice or applesauce. The latter works best for users who have difficulty swallowing pills. Granules cannot be mixed with water or any other liquids.

Users who take this medication for one year or longer risk weakening their stomach lining and becoming deficient in vitamin B12. Common Protonix side effects include headache, nausea, diarrhea, abdominal pain, vomiting, gas dizziness and joint pain.

Rabeprazole (Aciphex)

Aciphex is manufactured by Eisai. Doctors prescribe Rabeprazole to alleviate symptoms of GERD, to treat stomach ulcers and to eliminate the bacteria H. pylori.

Rabeprazole can be taken as a capsule for up to 12 weeks, usually once per day. It is a delayed-release medication, so it is broken down in the intestine rather than the stomach. When used to treat H. pylori infections, Rabeprazole is taken twice a day, after morning and evening meals.

In adults, the most common side effects are sore throat, gas, infection and constipation. In adolescents, the most common side effects of Aciphex are headache, diarrhea, nausea, vomiting, and abdominal pain. Users over age 50 should consult their doctors before taking Rabeprazole, as they are more likely to experience severe diarrhea and bone breaks.

Dosage and Administration

Patients usually take these drugs orally as pills or liquids and sometimes intravenously in hospitals. Most PPIs are taken once daily, but some patients benefit from twice-daily dosing.

These medications vary widely in their dosage instructions. Often, patients must take PPIs between 30 minutes and one hour prior to eating, but others do not have such stipulations. Some must be taken with a full glass of water, while others must be taken without water. Each PPI comes with its own set of instructions, and users must follow them carefully.

Many pregnant women suffer from GERD (gastroesophageal reflux disease) and seek a remedy. Doctors often prescribe H2 blockers and antacids, and reserve PPIs for the most severe cases of GERD in pregnant women. Short-term use of PPIs is supposed to be safe for children and even infants, so long as a doctor supervises the dosages. However, not enough studies exist on safety for these age groups.

Proton pump inhibitors are often the go-to drugs for doctors who see patients suffering from acid-related illnesses such as GERD and EE (erosive esophagitis). However, when users stop taking PPIs, symptoms tend to return quickly and viciously. PPIs do not cure acid-related conditions — they simply manage the symptoms. Thus, these medications should not be viewed as a long-term solution.

Many medical experts agree that doctors prescribe PPIs too generally when they should only be used as a last resort. Frequently, the patient’s issue can be resolved with the use of an over-the-counter antacid or lifestyle changes. In fact, one Michigan doctor studied 1,000 PPI users and found that only one-third of them had a diagnosis that merited a PPI prescription. Due to the negligence of overprescribing doctors, innocent patients suffered the consequences of unnecessary PPI use.

Alternatives to Proton Pump Inhibitors

The market offers many drugs that aid in acid-related issues, and PPIs are just one option. For example, antacids are available over the counter, and often spell a fast, easy fix for occasional heartburn. They neutralize gastric acid, so the user experiences less irritation. If a patient experiences heartburn more than twice per week, then it is necessary to seek a doctor’s advice rather than rely upon antacids for symptom management.

Other alternatives for acid-related problems are H2 blockers, which also work to reduce gastric acid secretions in the stomach. They can be used in conjunction with antacids for maximum effectiveness. H2s can be used as a long-term solution for management of acid-related problems.

Another option is promotility agents. These drugs discourage gastric acid production by blocking the activities of histamines, the agents responsible for stimulating acid production. H2 blockers work especially well against heartburn and acid reflux, but are not an ideal treatment for esophagitis.

Legal Actions

In 2015 alone, American courts saw settlements of three successful lawsuits involving PPIs, which totaled $51.9 million in payouts from PPI manufacturers.

Nexium manufacturer AstraZeneca paid out $20 million, after an extended lawsuit surrounding the company’s inappropriate promotion of Nexium. AstraZeneca communicated to users that Nexium was a better choice than a very similar but less expensive drug.

Also, AstraZeneca paid $7.9 million after U.S. government attorneys showed that the manufacturer had arranged a kickback scheme intended to make profits for the company at the expense of users.

Additionally, Teva Pharmaceuticals paid out $24 million after being found liable for keeping a less expensive Nexium alternative off the shelves.

Attorneys are now taking cases from patients who were harmed by PPIs. If successful, defective medication lawsuits can result in payouts to those who suffered from taking these dangerous drugs.